510(k) K052341
K052341 is an FDA 510(k) premarket notification submitted by Jpi America, Inc. for the device "AJEX 9015/135H PORTABLE X-RAY". The FDA issued a decision of Substantially Equivalent on October 7, 2005. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Jpi America, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2005
- Date Received
- August 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type